Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
Predicate lineage
Cited as predicate by: K121029, K121055, K121056, K123501, K131684, K141331, K141653, K142814, K190100, K192683, K200959
Cited as predicate by: K101475
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- TT MB Peg LIMACORPORATE SPA
- TT MB Peg LIMACORPORATE SPA
- USTAR II Knee System UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.
- """UNITED"" USTAR II Hip System" UNITED ORTHOPEDIC CORP.